BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 6477366 · Received April 10, 2017

    Report

    Report Number
    3012307300-2017-00819
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 17, 2017
    Report Date
    May 25, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IT WAS DETERMINED THAT THE REPORTED EVENT DATE WAS UNKNOWN AND NOT (B)(6) 2017 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT FOUR DEVICES CONTRIBUTED TO FOUR REPORTED EVENTS (ONE DEVICE PER EVENT). THE CUSTOMER RETURNED ONE DEVICE FOR EVALUATION. IT COULD NOT BE DETERMINED WHICH REPORTED OCCURRENCE WAS ASSOCIATED WITH THE RETURNED DEVICE; THEREFORE, THE EVALUATION OF THE RETURNED DEVICE WILL BE USED FOR THE MEDWATCHES. THE FOLLOWING MFR WERE SUBMITTED RELATED TO THE EVALUATION: 3012307300-2017-00819, 3012307300-2017-00825, 3012307300-2017-00826, AND 3012307300-2017-00827. ONE PORTEX® 8.0 MM BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED AND NO NON-CONFORMITIES WERE FOUND. DURING VISUAL AND FUNCTIONAL TESTING OF THE RETURNED DEVICE A 1.34 MM SLICE IN THE DEVICE CUFF WAS FOUND. IT WAS DETERMINED THAT THE OBSERVED CUT WAS NOT DUE TO A MANUFACTURING ISSUES AS THE DEVICES ARE 100% LEAK TESTED PRIOR TO RELEASE. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU), "GUARD AGAINST PRODUCT DAMAGE BY AVOIDING CONTACT WITH SHARP OBJECTS." INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE OBSERVED CUT WAS USE OF THE DEVICE IN A MANNER INCONSISTENT FROM THE DEVICE INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS ALTERED TO MALFUNCTION REPORTABLE BASED UPON THE ADDITIONAL INFORMATION THAT WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE LEAKED WITHIN A WEEK OF USE. THE ISSUE WAS OBSERVED BY THE PATIENT'S FAMILY SPONTANEOUSLY. IT WAS OBSERVED THAT THE SEAMS WERE PERFORATED IN THE MIDDLE OF THE CUFF. THE CUFF INTEGRITY WAS TESTED PRIOR TO USE. THE CUFF HAD BEEN FILLED WITH 7-8 ML OF STERILE WATER. DUE TO THE ISSUE, THE PATIENT WENT TO THE HOSPITAL FOR A TRACHEOSTOMY TUBE CHANGE TO A SMALLER SIZE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00825, 3012307300-2017-00826, AND 3012307300-2017-00827.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT CUFF LEAK WAS INITIALLY NOTED DUE TO THE SOUND OF THE PATIENT'S RESPIRATION. IT WAS CLARIFIED THAT THE PATIENT'S HUSBAND, WHO WAS TRAINED IN TRACHEOSTOMY TUBE CHANGES, OBSERVED THE REPORTED CUFF LEAK AND PERFORMED A TRACHEOSTOMY TUBE CHANGE. THE PATIENT REMAINED IN HOME CARE DURING THE TRACHEOSTOMY TUBE CHANGE AND DID NOT NEED TO GO TO THE HOSPITAL. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257668 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3300505 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other